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临床试验/CTRI/2025/02/081391
CTRI/2025/02/081391
尚未招募
不适用

Efficacy of dapagliflozin in spectrum of chronic kidney disease

未提供1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2025年3月15日最近更新:

概览

阶段
不适用
状态
尚未招募
入组人数
112
试验地点
1
主要终点
To assess the trend of eGFR / serum creatinine and proteinuria over a period of six months after starting dapagliflozin

概览

简要总结

A study conducted in a rural tertiary care hospital in Central India aiming to investigate Efficacy of dapagliflozinin spectrum of chronic kidney disease . The rationale behind the study is to assess the trend of eGFR / serum creatinine and proteinuria over a period of six months after starting dapagliflozin& to look for Side effects in period of six months after starting medication and potentially improving patient outcomes. The study design is a cross-sectional study with a duration of 24 months, conducted at Acharya Vinoba Bhave Rural Hospital. The sample size is determined to be 112 patients meeting specific inclusion criteria. Data collection involves obtaining baseline demographic and clinical data, including age, gender, BMI, and blood pressure, and analyzing serum samples for various biochemical markers. Ethical considerations, including patient confidentiality and informed consent, are emphasized. The primary outcome is the to assess the trend of eGFR / serum creatinine and proteinuria over a period of six months after starting dapagliflozin. The abstract highlights the study’s potential contributions to CKD management in the rural Indian population.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients with type 1 diabetes mellitus., Patients with polycystic kidney disease., Patient with active urinary tract infection.

排除标准

  • Patients with type 1 diabetes mellitus., Patients with polycystic kidney disease, Patient with active urinary tract infection.

结局指标

主要结局

To assess the trend of eGFR / serum creatinine and proteinuria over a period of six months after starting dapagliflozin

时间窗: All parameters will be assessed at the baseline | at the time of enrollment at day 1 and 24 weeks after starting dapagliflozin

次要结局

  • To look for incidence of urinary tract infection, limb amputation, hypoglycemia in period of six months after starting medication(All parameters will be assessed at the baseline)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Twinkle Pawar

Datta Meghe Institute of Higher Education and Research

研究点 (1)

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